截至2016年4月，FDA新批准了通过了18种物质的FCN申请，并将这18种物质增加到有效FCN通告列表中。
具体物质如下：
1574 |
Poly(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. |
PTT MCC Biochem Company Ltd. |
Jan 1, 2016 |
1599 |
1-Propanaminium, N,N,N-trimethyl-3-[(1-oxo-2-propen-1-yl)amino]-, chloride (1:1), polymer with ethenamine and 2-propenamide, hydrochloride (CAS Reg. No. 1659307-53-5). |
Solenis LLC |
Jan 6, 2016 |
1600 |
A solution of silver dihydrogen citrate stabilized with sodium lauryl sulfate and citric acid. |
Pure Bioscience, Inc. |
Jan 7, 2016 |
1562 |
Carbon monoxide-ethylene-propylene terpolymer (CAS Reg. No. 88995-51-1). |
Hyosung Corporation |
Jan 9, 2016 |
1604 |
Isotridecanol phosphite condensation product with butylidenebis(2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene). |
ADEKA Corporation |
Jan 9, 2016 |
1605 |
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). |
BASF Corporation |
Jan 9, 2016 |
1583 |
Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0) and (b) Polyester/polyol component, prepared from adipic acid, diethylene glycol, methyloxirane polymer, and 1,1,1-tris(hydroxymethyl)propane. |
Henkel, Inc. |
Jan 15, 2016 |
1584 |
Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from polypropylene glycol, toluene diisocyanate, allophanate-modified methane diphenyl diisocyanate and 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), and (b) Polyester/polyol component, prepared from adipic acid, diethylene glycol, methyloxirane polymer, and 1,1,1-tris(hydroxymethyl)propane. |
Henkel, Inc. |
Jan 15, 2016 |
1578 |
Chlorine dioxide (CAS Reg. No. 10049-04-4). |
Selective Micro Technologies, LLC |
Jan 26, 2016 |
1580 |
An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4). |
Brainerd Chemical Company, Inc. |
Jan 26, 2016 |
1594 |
An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9). |
Valley Chemical Solutions |
Jan 26, 2016 |
1609 |
Agarose, polymer with 2‐(chloromethyl)oxirane, 2‐hydroxy‐3‐(2‐propen‐1‐yloxy)propyl ether, polymer with 1‐ethenyl‐2‐pyrrolidinone, graft (CAS Reg. No. 1613113‐98‐6). |
GE Healthcare Bio-Sciences AB |
Jan 26, 2016 |
1587 |
Tris(2-ethylhexyl) trimellitate (CAS Reg. No. 3319-31-1). |
BASF Corporation |
Jan 27, 2016 |
1615 |
Hexanoic acid, 3,5,5-trimethyl-, 1,1-[oxybis[2,2-bis[[(3,5,5-trimethyl-1-oxohexyl)oxy]methyl]-3,1-propanediyl]] ester (CAS Reg. No. 65870-97-5). |
NYCO |
Feb 3, 2016 |
1618 |
2,6-naphthalenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, [1,1'-biphenyl]-4,4'-diol and 4-hydroxybenzoic acid (CAS Reg. No. 126710-16-5). |
Chang Chun Plastics Co., Ltd. |
Feb 5, 2016 |
1595 |
An aqueous mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9). |
PeroxyChem LLC |
Feb 16, 2016 |
1596 |
Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0). (b) Polyester component (CAS Reg. No. 1429057-80-6) prepared by the reaction of 1,3-benzenedicarboxylic acid and diethylene glycol, trans-esterified with castor oil. |
Henkel, Inc. |
Feb 18, 2016 |
1597 |
Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from polypropylene glycol, toluene diisocyanate, allophanate-modified methane diphenyl diisocyanate and 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8). (b) Polyester component (CAS Reg. No. 1429057-80-6) prepared by the reaction of 1,3-benzenedicarboxylic acid and diethylene glycol, trans-esterified with castor oil. |
Henkel, Inc. |
Feb 18, 2016 |
美国奥巴马总统签署的2016年财政预算中5,000,000美元用于食品接触材料通告（FCN）的提交和审核。这意味着企业至少在2016年能受利于该财政拨款，免于食品接触通告提交的行政费。但是，在过去几年曾经出现过没有财政拨款导致FCN项目停滞的情况。
瑞欧提醒广大企业，若有意进行食品接触通告（FCN）提交，建议尽快启动相关项目，以防美国官方有新的政策出台，同时完成食品接触通告的提交能占得市场先机。
瑞欧在应对美国食品接触材料(FDA /FCN /21 CFR)方面有丰富的经验，可以为企业量身定制合规服务，提供合规解决方案。企业如果有进一步的疑问，欢迎咨询0571-8700 6630。
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